CO2018007810A2 - Formulación líquida estable de gonadotropina - Google Patents
Formulación líquida estable de gonadotropinaInfo
- Publication number
- CO2018007810A2 CO2018007810A2 CONC2018/0007810A CO2018007810A CO2018007810A2 CO 2018007810 A2 CO2018007810 A2 CO 2018007810A2 CO 2018007810 A CO2018007810 A CO 2018007810A CO 2018007810 A2 CO2018007810 A2 CO 2018007810A2
- Authority
- CO
- Colombia
- Prior art keywords
- gonadotropin
- liquid formulation
- stable liquid
- stabilization
- formulation
- Prior art date
Links
- 102000006771 Gonadotropins Human genes 0.000 title abstract 3
- 108010086677 Gonadotropins Proteins 0.000 title abstract 3
- 239000002622 gonadotropin Substances 0.000 title abstract 3
- 239000012669 liquid formulation Substances 0.000 title 1
- 238000009472 formulation Methods 0.000 abstract 3
- 239000000203 mixture Substances 0.000 abstract 3
- 230000006641 stabilisation Effects 0.000 abstract 2
- 238000011105 stabilization Methods 0.000 abstract 2
- 239000004475 Arginine Substances 0.000 abstract 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 abstract 1
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 abstract 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 229930182817 methionine Natural products 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Reproductive Health (AREA)
- Endocrinology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Pregnancy & Childbirth (AREA)
- Gynecology & Obstetrics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Abstract
RESUMEN La presente invención se refiere en general al campo de la estabilización de formulaciones de gonadotropina, en particular formulaciones líquidas de gonadotropinas. La estabilización se logra mediante una combinación particular de excipientes, preferiblemente arginina y metionina. En una realización preferida, la formulación no comprende tampón alguno.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB1603280.7A GB201603280D0 (en) | 2016-02-24 | 2016-02-24 | Stable liquid gonadotropin formulation |
| PCT/EP2017/054325 WO2017144659A1 (en) | 2016-02-24 | 2017-02-24 | Stable liquid gonadotropin formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO2018007810A2 true CO2018007810A2 (es) | 2018-10-22 |
Family
ID=55806922
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CONC2018/0007810A CO2018007810A2 (es) | 2016-02-24 | 2018-07-27 | Formulación líquida estable de gonadotropina |
Country Status (36)
| Country | Link |
|---|---|
| US (3) | US10792334B2 (es) |
| EP (3) | EP3791860B1 (es) |
| JP (3) | JP6932710B2 (es) |
| KR (1) | KR102756413B1 (es) |
| CN (2) | CN108883061B (es) |
| AR (1) | AR107782A1 (es) |
| AU (2) | AU2017222292B2 (es) |
| BR (1) | BR112018015166A2 (es) |
| CA (1) | CA3012759A1 (es) |
| CL (1) | CL2018001984A1 (es) |
| CO (1) | CO2018007810A2 (es) |
| DK (2) | DK3419595T3 (es) |
| EA (1) | EA036383B1 (es) |
| ES (2) | ES2966262T3 (es) |
| FI (1) | FI3791860T3 (es) |
| GB (1) | GB201603280D0 (es) |
| HR (2) | HRP20231477T1 (es) |
| HU (2) | HUE053492T2 (es) |
| IL (1) | IL260626B2 (es) |
| JO (1) | JOP20170046B1 (es) |
| LT (2) | LT3791860T (es) |
| MA (2) | MA43686B1 (es) |
| MD (2) | MD3419595T2 (es) |
| MX (1) | MX381709B (es) |
| MY (1) | MY193138A (es) |
| PH (1) | PH12018501688B1 (es) |
| PL (2) | PL3419595T3 (es) |
| PT (2) | PT3419595T (es) |
| RS (2) | RS61604B1 (es) |
| SG (1) | SG11201806140SA (es) |
| SI (2) | SI3791860T1 (es) |
| TN (1) | TN2018000284A1 (es) |
| TW (1) | TWI755377B (es) |
| UA (1) | UA123107C2 (es) |
| WO (1) | WO2017144659A1 (es) |
| ZA (1) | ZA201804944B (es) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB201603280D0 (en) * | 2016-02-24 | 2016-04-13 | Ferring Bv | Stable liquid gonadotropin formulation |
| WO2019164765A1 (en) * | 2018-02-26 | 2019-08-29 | Slayback Pharma Llc | Ready-to-use dexmedetomidine compositions |
| CA3115186A1 (en) * | 2018-10-02 | 2020-04-09 | InnoCore Technologies Holding B.V. | Extended release formulations of human chorionic gonadotropin (hcg) |
| CN114404575A (zh) * | 2020-12-07 | 2022-04-29 | 苏州智核生物医药科技有限公司 | 一种重组人促甲状腺素注射液 |
| WO2022197963A1 (en) * | 2021-03-19 | 2022-09-22 | Pfizer Inc. | Long-acting growth hormone compositions |
| CN118209739A (zh) * | 2024-03-19 | 2024-06-18 | 厦门宝太和瑞生物技术有限公司 | 促黄体生成素检测试剂盒 |
| KR102821987B1 (ko) * | 2024-10-24 | 2025-06-26 | 에이디텍 주식회사 | 베타 코어 단편 hCG를 유효성분으로 포함하는 난임 치료용 조성물 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0803832A3 (en) | 1996-02-28 | 2000-05-31 | Hitachi, Ltd. | Card holder-type balance display |
| TW518235B (en) * | 1997-01-15 | 2003-01-21 | Akzo Nobel Nv | A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage |
| JP4719357B2 (ja) * | 1998-07-23 | 2011-07-06 | アレス トレイディング ソシエテ アノニム | Ｆｓｈ及びｆｓｈ変異体の製剤、製品及び方法 |
| BRPI0611901A2 (pt) | 2005-06-14 | 2012-08-28 | Amgen, Inc | composição, liofilizado, kit, e, processo para preparar uma composição |
| KR101105871B1 (ko) * | 2005-09-27 | 2012-01-16 | 주식회사 엘지생명과학 | 인 난포자극호르몬의 안정한 용액 제형 |
| GB0700523D0 (en) | 2007-01-11 | 2007-02-21 | Insense Ltd | The Stabilisation Of Proteins |
| KR101513181B1 (ko) * | 2007-11-01 | 2015-04-21 | 메르크 세로노 에스. 에이. | Ｌｈ 액체 제형 |
| US8420081B2 (en) | 2007-11-30 | 2013-04-16 | Abbvie, Inc. | Antibody formulations and methods of making same |
| PE20091174A1 (es) * | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| EP2412385A1 (en) | 2008-02-08 | 2012-02-01 | BioGeneriX AG | Liquid formulation of FSH |
| TWI488640B (zh) | 2008-04-16 | 2015-06-21 | Ferring Int Ct Sa | 藥學製劑 |
| AU2009312235B2 (en) * | 2008-11-04 | 2014-01-16 | Aska Pharmaceutical Co., Ltd. | Aqueous composition containing follicle-stimulating hormone |
| EP2533800B1 (en) | 2010-02-12 | 2016-07-20 | Intas Pharmaceuticals Ltd. | Liquid formulation of follicle stimulating hormone |
| WO2011108010A2 (en) | 2010-03-05 | 2011-09-09 | Intas Biopharmaceuticals Limited | A thermostable liquid formulation of gonadotropins |
| EP2417982A1 (en) * | 2010-07-30 | 2012-02-15 | Ferring B.V. | Stabilization of gonadotropins |
| CN105658201A (zh) * | 2013-11-12 | 2016-06-08 | 卡迪拉保健有限公司 | 促性腺激素的制剂 |
| GB201603280D0 (en) | 2016-02-24 | 2016-04-13 | Ferring Bv | Stable liquid gonadotropin formulation |
-
2016
- 2016-02-24 GB GBGB1603280.7A patent/GB201603280D0/en not_active Ceased
-
2017
- 2017-02-19 JO JOP/2017/0046A patent/JOP20170046B1/ar active
- 2017-02-23 TW TW106106132A patent/TWI755377B/zh active
- 2017-02-24 SI SI201731448T patent/SI3791860T1/sl unknown
- 2017-02-24 SG SG11201806140SA patent/SG11201806140SA/en unknown
- 2017-02-24 MA MA43686A patent/MA43686B1/fr unknown
- 2017-02-24 PH PH1/2018/501688A patent/PH12018501688B1/en unknown
- 2017-02-24 BR BR112018015166A patent/BR112018015166A2/pt active Search and Examination
- 2017-02-24 ES ES20202758T patent/ES2966262T3/es active Active
- 2017-02-24 ES ES17707527T patent/ES2862193T3/es active Active
- 2017-02-24 KR KR1020187027128A patent/KR102756413B1/ko active Active
- 2017-02-24 HR HRP20231477TT patent/HRP20231477T1/hr unknown
- 2017-02-24 US US16/079,428 patent/US10792334B2/en active Active
- 2017-02-24 RS RS20210361A patent/RS61604B1/sr unknown
- 2017-02-24 DK DK17707527.2T patent/DK3419595T3/da active
- 2017-02-24 PL PL17707527T patent/PL3419595T3/pl unknown
- 2017-02-24 EP EP20202758.7A patent/EP3791860B1/en active Active
- 2017-02-24 LT LTEP20202758.7T patent/LT3791860T/lt unknown
- 2017-02-24 CA CA3012759A patent/CA3012759A1/en active Pending
- 2017-02-24 TN TNP/2018/000284A patent/TN2018000284A1/en unknown
- 2017-02-24 PT PT177075272T patent/PT3419595T/pt unknown
- 2017-02-24 MY MYPI2018001301A patent/MY193138A/en unknown
- 2017-02-24 AR ARP170100475A patent/AR107782A1/es unknown
- 2017-02-24 MA MA52595A patent/MA52595B1/fr unknown
- 2017-02-24 AU AU2017222292A patent/AU2017222292B2/en active Active
- 2017-02-24 CN CN201780013134.9A patent/CN108883061B/zh active Active
- 2017-02-24 WO PCT/EP2017/054325 patent/WO2017144659A1/en active Application Filing
- 2017-02-24 EP EP23194814.2A patent/EP4257149A3/en not_active Withdrawn
- 2017-02-24 DK DK20202758.7T patent/DK3791860T5/da active
- 2017-02-24 PT PT202027587T patent/PT3791860T/pt unknown
- 2017-02-24 MX MX2018010201A patent/MX381709B/es unknown
- 2017-02-24 LT LTEP17707527.2T patent/LT3419595T/lt unknown
- 2017-02-24 EA EA201891905A patent/EA036383B1/ru not_active IP Right Cessation
- 2017-02-24 EP EP17707527.2A patent/EP3419595B1/en active Active
- 2017-02-24 FI FIEP20202758.7T patent/FI3791860T3/fi active
- 2017-02-24 RS RS20231172A patent/RS64929B1/sr unknown
- 2017-02-24 HU HUE17707527A patent/HUE053492T2/hu unknown
- 2017-02-24 PL PL20202758.7T patent/PL3791860T3/pl unknown
- 2017-02-24 HR HRP20210367TT patent/HRP20210367T1/hr unknown
- 2017-02-24 UA UAA201809497A patent/UA123107C2/uk unknown
- 2017-02-24 MD MDE20190039T patent/MD3419595T2/ro unknown
- 2017-02-24 HU HUE20202758A patent/HUE064432T2/hu unknown
- 2017-02-24 CN CN202110585922.3A patent/CN113398250B/zh active Active
- 2017-02-24 SI SI201730666T patent/SI3419595T1/sl unknown
- 2017-02-24 JP JP2018544561A patent/JP6932710B2/ja active Active
- 2017-02-24 MD MDE20210250T patent/MD3791860T2/ro unknown
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2018
- 2018-07-17 IL IL260626A patent/IL260626B2/en unknown
- 2018-07-23 CL CL2018001984A patent/CL2018001984A1/es unknown
- 2018-07-23 ZA ZA2018/04944A patent/ZA201804944B/en unknown
- 2018-07-27 CO CONC2018/0007810A patent/CO2018007810A2/es unknown
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2020
- 2020-09-14 US US17/020,279 patent/US11666635B2/en active Active
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2021
- 2021-08-18 JP JP2021133422A patent/JP2021191760A/ja active Pending
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2022
- 2022-01-05 AU AU2022200027A patent/AU2022200027A1/en not_active Abandoned
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2023
- 2023-04-21 US US18/138,000 patent/US20230372447A1/en active Pending
- 2023-09-15 JP JP2023150308A patent/JP2023164573A/ja active Pending
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